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Direct Healthcare Professional Communication (DHPC) on 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: pre-treatment testing to identify DPD-deficient patients

Active substance: 5-fluorouracil, capecitabine, tegafur

The marketing authorisation holders of medicines containing 5-fluorouracil i.v. (5-FU), capecitabine or tegafur, would like to inform you in agreement with the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) that patients with partial or complete dihydropyrimidine dehydrogenase (DPD) deficiency are at an increased risk of severe toxicity during treatment with fluoropyrimidines (5-FU i.v., capecitabine, tegafur). Phenotype and/or genotype testing before initiation of treatment with fluoropyrimidines is recommended.

Download DHPC / Information letter , Download_VeroeffentlichtAm_EN PDF, 109KB, File is accessible